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| Name | Class |
|---|---|
| Ontario Institute for Cancer Research | OTHER |
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The purpose of this study is to compare the daily pain level scores for patients taking opioids alone for pain relief, compared with those treated by multimodal analgesia with three medications: pregabalin, naproxen, and acetaminophen, with the ability to switch over to opioid medications if needed. In addition to pain level scores, this study will compare opioid use (length of time and doses taken), quality of life, admissions to hospital, feeding tube requirements, weight loss, and treatment interruptions between these two analgesic regimens.
A significant proportion of patients undergoing radiotherapy alone or chemotherapy and radiotherapy together for their head and neck cancer experience mucositis, which is severe pain in the mouth and throat caused by radiation treatment. Patients often enter a cycle of pain, difficulty swallowing, malnourishment, and reduced quality of life. This may translate into decreased oral intake requiring a feeding tube, and radiation or chemotherapy treatment breaks, which reduce the chance of tumour control and cure.
Currently, opioid therapy is the cornerstone of head and neck cancer pain management. Although effective for pain relief, opioids can have side effects.
As an alternative to opioid treatments, "multimodal analgesia" is a treatment using medications from different classes with different mechanisms of action. Examples of analgesic medications used for multimodal analgesia include medications similar to acetaminophen or ibuprofen, and others.
The primary purpose of this study is to compare pain level scores of patients taking opioids versus patients taking multimodal analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Analgesia | Active Comparator | Opioids will be prescribed as per institutional standards. Examples of opioids are morphine and hydromorphone. |
|
| Multimodal Analgesia | Experimental | Pregabalin (50 mg to 300 mg, oral, twice daily), acetaminophen (1000 mg, oral, 3 times per day), naproxen 250 mg to 500 mg, oral, twice daily), and pantoprazole magnesium (40 mg, oral, daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioids | Drug | Opioids will be prescribed as per institutional standards. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Rating measured on the 11 Numeric Rating Scale | Average pain rating during the last 7 days of radiation therapy, as reported by the patient on the 11-Numeric Rating Scale (11-NRS). On the 11-NRS, zero (0) is no pain, and ten (10) is the worst possible pain. | Approximately 2 years and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Weekly Opioid Use | The average weekly total opioid dose in oral morphine equivalent dosing from randomization to 6 weeks after completion of radiation treatment. | Approximately 2 years and 4 months |
| Duration of Opioid Requirement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Palma, MD | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Regional Cancer Program of the Lawson Health Research Institute | London | Ontario | N6A 4L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30990535 | Background | Elad S, Yarom N. The Search for an Effective Therapy and Pain Relief for Oral Mucositis. JAMA. 2019 Apr 16;321(15):1459-1461. doi: 10.1001/jama.2019.3269. No abstract available. | |
| 24615748 | Background | Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, McGuire DB, Migliorati C, Nicolatou-Galitis O, Peterson DE, Raber-Durlacher JE, Sonis ST, Elad S; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014 May 15;120(10):1453-61. doi: 10.1002/cncr.28592. Epub 2014 Feb 25. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| PAiN - multimodal analgesia |
| Drug |
PAiN: Pregabalin, Acetaminophen, Naproxen, pantoprazole magnesium |
|
The time from the start of opioid treatment after randomization to the time of stopping opioid analgesia, in days.
| Approximately 2 years and 6 months |
| Average Daily 11-Numeric Rating Scale for Pain | Average pain rating from the time of randomization until 6 weeks after completion of radiation treatment, as reported by the patient on the 11-Numeric Rating Scale (11-NRS). On the 11-NRS, zero (0) is no pain, and ten (10) is the worst possible pain. | Approximately 2 years and 4 months |
| Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) | Quality of life, as reported by the patient, will be assessed using the EORTC QLQ-C30 validated questionnaire. Responses regarding function and symptoms are on a scale of 1 (not at all) to 4 (very much). Also included are questions about overall health and quality of life. Responses are on a scale of 1 (very poor) to 7 (excellent). | Approximately 24 months, 27 months, and 30 months |
| Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head & Neck 43 (EORTC QLQ-HN 43) | Quality of life, as reported by the patient, will be assessed using the EORTC QLQ-HN 43 validated questionnaire. Responses regarding symptoms or problems are on a scale of 1 (not at all) to 4 (very much). This questionnaire is specifically for patients with head and neck cancer. | Approximately 24 months, 27 months, and 30 months |
| Average Weekly Opioids Dispensed | The average weekly total opioid dose dispensed by the pharmacy in oral morphine equivalent dosing from randomization to 6 weeks after completion of radiation treatment. | Approximately 2 years and 4 months |
| Hospital Admissions | Hospital admissions for febrile neutropenia, serious infection requiring intravenous antibiotics, gastrointestinal bleeding, myocardial infarction, stroke, and acute kidney injury. | Approximately 27 months and 30 months |
| Time to Feeding Tube Insertion | The time to feeding tube insertion (e.g. gastrostomy-tube or nasogastric-tube) after randomization, in days. | Approximately 2 years and 3 months |
| Weight Loss | Weight loss from randomization to the end of radiation treatment. | Approximately 2 years and 3 months |
| Rates of Common Terminology Criteria for Adverse Events Toxicities | Rates of pre-specified Common Terminology Criteria for Adverse Events (CTCAE) toxicities. | Approximately 2 years and 6 months |
| Treatment Interruptions | Number of participants with radiation of chemotherapy treatment interruptions. | Approximately 2 years and 6 months |
| Death | Number of participants who die during or within 3 months after completion of radiation treatment. | Approximately 2 years and 6 months |
| 26712589 | Background | Mirabile A, Airoldi M, Ripamonti C, Bolner A, Murphy B, Russi E, Numico G, Licitra L, Bossi P. Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. Crit Rev Oncol Hematol. 2016 Mar;99:100-6. doi: 10.1016/j.critrevonc.2015.11.010. Epub 2015 Dec 3. |
| 26849016 | Background | Alfieri S, Ripamonti CI, Marceglia S, Orlandi E, Iacovelli NA, Granata R, Cavallo A, Pozzi P, Boffi R, Bergamini C, Imbimbo M, Pala L, Resteghini C, Mirabile A, Locati LD, Licitra L, Bossi P. Temporal course and predictive factors of analgesic opioid requirement for chemoradiation-induced oral mucositis in oropharyngeal cancer. Head Neck. 2016 Apr;38 Suppl 1:E1521-7. doi: 10.1002/hed.24272. Epub 2016 Feb 5. |
| 40054624 | Derived | Zayed S, Lang P, Read N, Correa RJM, Mutsaers A, Goodman CD, D'Angelo K, Kieraszewicz K, Vanwynsberghe D, Kingsbury-Paul A, Crewdson K, Neeb J, Carreau C, Winquist E, Kuruvilla S, Stewart P, Moulin DE, Warner A, Palma DA. Opioid therapy vs. Multimodal analgesia in head and neck cancer (OPTIMAL-HN): Results of a randomized clinical trial. Radiother Oncol. 2025 May;206:110831. doi: 10.1016/j.radonc.2025.110831. Epub 2025 Mar 5. |
| 33740977 | Derived | Zayed S, Lang P, Mendez LC, Read N, Sathya J, Venkatesan V, Moulin DE, Warner A, Palma DA. Opioid therapy vs. multimodal analgesia in head and neck Cancer (OPTIMAL-HN): study protocol for a randomized clinical trial. BMC Palliat Care. 2021 Mar 19;20(1):45. doi: 10.1186/s12904-021-00735-0. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |